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Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

Primary Purpose

Encephalitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Live attenuated chimeric Japanese Encephalitis vaccine
Inactivated Hepatitis A vaccine
Sponsored by
Siriraj Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Encephalitis focused on measuring Live attenuated Japanese Encephalitis vaccine, IMOJEV, CD.JEVAX, Booster, Thai children, Immunogenicity, Safety, Interchangeability, Hepatitis A vaccine, Vaccination or Other Immunization Procedure

Eligibility Criteria

1 Year - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children aged 1 to <5 years on the day of inclusion
  • History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
  • In good general health at the time of inclusion
  • Provision of informed consent by the parent(s) or legal guardian(s)

Exclusion Criteria:

  • Receipt of blood or blood products in the past 3 months
  • Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
  • Previous receipt of 2 doses of any vaccine against JE virus
  • Known hypersensitivity to any of the vaccine components
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Imojev

    Arm Description

    Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
    Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).

    Secondary Outcome Measures

    Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
    Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.
    Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™
    Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.

    Full Information

    First Posted
    August 9, 2015
    Last Updated
    October 13, 2016
    Sponsor
    Siriraj Hospital
    Collaborators
    Sanofi Pasteur, a Sanofi Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02526550
    Brief Title
    Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
    Official Title
    Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Siriraj Hospital
    Collaborators
    Sanofi Pasteur, a Sanofi Company

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.
    Detailed Description
    The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Encephalitis
    Keywords
    Live attenuated Japanese Encephalitis vaccine, IMOJEV, CD.JEVAX, Booster, Thai children, Immunogenicity, Safety, Interchangeability, Hepatitis A vaccine, Vaccination or Other Immunization Procedure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Imojev
    Arm Type
    Experimental
    Arm Description
    Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
    Intervention Type
    Biological
    Intervention Name(s)
    Live attenuated chimeric Japanese Encephalitis vaccine
    Other Intervention Name(s)
    Imojev
    Intervention Description
    0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
    Intervention Type
    Biological
    Intervention Name(s)
    Inactivated Hepatitis A vaccine
    Other Intervention Name(s)
    Havrix
    Intervention Description
    0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
    Description
    Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).
    Time Frame
    Day 0 (Baseline) and Day 28 (post-vaccination)
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
    Description
    Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.
    Time Frame
    Day 0 (Baseline) and Day 28 (post-vaccination)
    Title
    Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™
    Description
    Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.
    Time Frame
    Up to 28 days post booster vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children aged 1 to <5 years on the day of inclusion History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment In good general health at the time of inclusion Provision of informed consent by the parent(s) or legal guardian(s) Exclusion Criteria: Receipt of blood or blood products in the past 3 months Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C) Previous receipt of 2 doses of any vaccine against JE virus Known hypersensitivity to any of the vaccine components Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kulkanya Chokephaibulkit, Professor
    Organizational Affiliation
    Siriraj Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The submission of study review and results to a peer-review journal is ongoing.
    Citations:
    PubMed Identifier
    27846060
    Citation
    Sricharoenchai S, Lapphra K, Chuenkitmongkol S, Phongsamart W, Bouckenooghe A, Wittawatmongkol O, Rungmaitree S, Chokephaibulkit K. Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine as a Booster Dose After Primary Vaccination With Live Attenuated SA14-14-2 Vaccine: A Phase IV Study in Thai Children. Pediatr Infect Dis J. 2017 Feb;36(2):e45-e47. doi: 10.1097/INF.0000000000001395.
    Results Reference
    derived

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    Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

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